FDA Inspection
InControl Medical, LLCInControl Medical, LLC – FDA Inspection, Feb 14, 2017
Record Details
This FDA Inspection record concerns InControl Medical, LLC, with an inspection on February 14, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Richard J. Tucker (Issuing Officer)
View Company Profile
ID · f313ae67-b284-41c9-89be-ee9b5c631a73
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1016485
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.100(b)Documentation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of InControl Medical, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 17, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 21, 2012 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for InControl Medical, LLC
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.